S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)

SWOG Cancer Research Network

Status: Completed

Conditions: Stage IIIA Breast Cancer; Febrile Neutropenia; Stage IIA Breast Cancer; Stage IVA Colorectal Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage 0 Breast Cancer; Stage IIB Colorectal Cancer; Stage IV Non-Small Cell Lung Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IA Breast Cancer; Stage IIIA Non-Small Cell Lung Cancer; Stage IA Non-Small Cell Lung Carcinoma; Stage 0 Colorectal Cancer; Stage IIB Non-Small Cell Lung Carcinoma; Stage I Colorectal Cancer; Stage IIIB Colorectal Cancer; Stage IIB Breast Cancer; Stage IB Non-Small Cell Lung Carcinoma; Stage IVB Colorectal Cancer; Stage IIC Colorectal Cancer; Stage IIIA Colorectal Cancer; Stage IIIC Colorectal Cancer; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIA Colorectal Cancer; Stage IB Breast Cancer; Stage 0 Non-Small Cell Lung Cancer; Stage IV Breast Cancer

Treatments: Other: Questionnaire Administration; Other: Preventive Intervention; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT02728596

UG1CA189974 (U.S. NIH Grant/Contract)

NCI-2016-00264 (Registry Identifier)

S1415CD (Other Identifier)

SWOG-S1415CD (Other Identifier)

S1415

Details and patient eligibility

About

This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the risk of infection. Colony stimulating factors are medications sometimes given to patients receiving chemotherapy to prevent febrile neutropenia. Colony stimulating factors are given to patients based on guidelines. Some clinics have an automated system that helps doctors decide when to prescribe them when there is a high risk of developing febrile neutropenia. Gathering information about the use of an automated system to prescribe prophylactic colony stimulating factor may help doctors use colony stimulating factor when it is needed.

Full description

PRIMARY OBJECTIVES:

I. To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among patients registered at intervention components versus usual care components.

II. To compare the rate of febrile neutropenia (FN) among patients registered at intervention components versus usual care components.

III. To compare the rate of FN among intermediate risk patients registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

SECONDARY OBJECTIVES:

I. To compare the rate of FN among low-risk patients registered at intervention components versus usual care components.

II. To compare the FN-related health-related quality of life (HRQOL) among low-risk patients registered at intervention components versus usual care components.

III. To compare patient adherence to PP-CSF prescribing among patients registered at intervention components versus usual care components.

IV. To compare patient knowledge of the indications for, efficacy of, and side effects associated with PP-CSF between the initiation and conclusion of the first cycle of myelosuppressive systemic therapy among patients registered at intervention components versus usual care components.

V. To compare the proportion of patients completing the initial systemic therapy regimen at planned duration and at planned dose intensity among patients registered at intervention components versus usual care components.

VI. To compare antibiotic use both as prophylaxis and as treatment for FN among patients registered at intervention components versus usual care components.

VII. To compare the rate of FN-related emergency department visits and hospitalizations among intermediate risk patients registered to Intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

VIII. To compare the FN-related health-related quality of life (HRQOL) among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

IX. To compare overall survival among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

TERTIARY OBJECTIVES:

I. To characterize and descriptively report the differences among cohort components and the intervention and usual care components.

II. To evaluate the time to invasive recurrence in non-metastatic patients by component treatment assignment

OUTLINE: Patients are randomized to 1 of 4 clinic groups.

CLINIC GROUP 1 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN.

CLINIC GROUP 2 (CLINIC WITH NO AUTOMATED SYSTEM): Patients receive CSF based on clinical practice guidelines.

CLINIC GROUP 3 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high or moderate risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN.

CLINIC GROUP 4 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSF not be used for drugs that have a moderate risk of FN.

After completion of study treatment, patients are followed up for 12 months.

Enrollment: 3,665 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic
• Patients must be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage 9or disease setting).
• Patients must not have had any systemic therapy (chemotherapy or combination regimens) in the 180 days just prior to registration. Prior biologic therapy, immunotherapy, tyrosine kinase inhibitors, and hormonal therapy are allowed.
• Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted. This treatment may be neoadjuvant or adjuvant chemotherapy.
• Patients must not be receiving or planning to receive concurrent radiation during systemic treatment.
• Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim
• Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish
• Patients may have had a prior malignancy
• Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,665 participants in 4 patient groups

Clinic group 1 (clinics with existing automated system for CSF prescribing)

Active Comparator group

Description:

CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Preventive Intervention

Clinic group 2 (clinics with no automated system for CSF prescribing)

Active Comparator group

Description:

CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Preventive Intervention

Clinic group 3 (clinics with automated system for CSF prescribing)

Experimental group

Description:

CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Preventive Intervention

Clinic group 4 (clinics with automated system for CSF prescribing)

Experimental group

Description:

CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Preventive Intervention